Clinical Trials

Date: 2015-11-18

Type of information: Initiation of the trial

phase: 1b/3

Announcement: initiation of the trial

Company: Amgen (USA - CA) Merck&Co (USA - NJ)

Product: Keytruda® (pembrolizumab) and talimogene Laherparepvec

Action mechanism:

monoclonal antibody/immune checkpoint inhibitor/oncolytic virus/immunotherapy product. Keytruda® (pembrolizumab - MK-3475) is an highly selective monoclonal anti-PD-1 antibody designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking PD-1, pembrolizumab enables activation of the immune system’s T-cells that target cancer by essentially releasing a brake on the immune system.
Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumors (but not normal tissue) and to initiate an immune response to target cancer cells that have metastasized. Talimogene laherparepvec was designed to work in two important and complementary ways. First, it is injected directly into tumors where it replicates inside the tumor's cells causing the cell to rupture and die in a process called lysis. The rupture of the cancer cells can release tumor-derived antigens, along with GM-CSF, that can stimulate a system-wide immune response where white blood cells are able to seek out and target cancer that has spread throughout the body.

Disease: carcinoma of the head and neck

Therapeutic area: Cancer - Oncology

Country: Australia, Belgium, Canada, France, Greece, Spain, Switzerland, UK, USA

Trial details:

MASTERKEY232 / KEYNOTE-137 is a Phase 1b/3 multicenter, randomized, trial of talimogene laherparepvec in combination with pembrolizumab for the treatment of subjects with recurrent or metastatic squamous cell carcinoma of the head and neck. (NCT02626000)

Latest news:

• On November 18, 2015, a Phase I trial sponsored by Amgen was published on the NIH website ClinicalTrials.gov for pembrolizumab and talimogene Laherparepvec and is currently recruiting participants.